This medical device report is filed retrospectively following fda observation number 4 received by degania medical devices pvt.Ltd.During the fda inspection of 4-7 of november 2019.The observation was related to the fact that degania medical devices pvt.Ltd.Did not establish procedures for reporting mdrs to fda as a manufacturer.Till then all complaints related to the devices produced by dmd were assessed for mdr reportability and submitted as necessary to fda by degania silicone ltd.Another q medical devices division closely affiliated with dmd.Dmd capa number (b)(4) was issued to address the observation; one of the capa actions requires dmd to perform retrospective review of all the complaints received during 2018 and 2019 and submit to fda retrospective mdrs for the reportable events (with reference to original reported to fda report # 8030107-2019-00020 filed by degania silicone ltd.) in summary, until the catheter is checked, it is not possible to conclude that the catheter had any malfunction.We close this complaint as not justified.
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This is retrospective submission, following reassessment of our customer complaints during period 2018-2019.Customer's text: according to the reporter, it was reported that a (b)(6) yo, male patient, weighing (b)(6)kg admitted for burn over 40% of the body, currently unstable condition, in the icu being treated for burns, respiratory assistance, and sepsis.Urinary catheter inserted on (b)(6) 2018, and (b)(6) 2018, and patient became very unstable, temperature monitoring from foley measured 37.6 degree centigrade while esophageal measurement showed 41.1 degree centigrade.Patient was called down via multiple methods.Due to edema of genitals it is not possible to remove catheter at this time, but customer reported once they are able to remove it, product will be sent for failure investigation.
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